Vessel occluding material extractor

ABSTRACT

Methods, devices, and systems for extracting vessel occluding material are provided. An embodiment of a vessel occluding material extractor includes a host structure, a plurality of expandable members, a slide mechanism, and a circumferential member. The host structure has an elongate axis. The expandable members are connected to the host structure arrayed radially around the elongate axis. The slide mechanism is connected to the expandable members and adjacent the host structure, and is slidable in the direction of the elongate axis. The circumferential member is connected to the expandable members between the connection of the slide mechanism and the host structure to the expandable members.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/411,558 filed Apr. 10, 2003.

INTRODUCTION

Intravascular devices are used in various medical procedures. Forexample, certain intravascular devices, such as catheters and guidewiresare generally used to deliver fluids or other medical devices tospecific locations within a patient's body, such as within the vascularsystem. Various devices are also used in treating specific conditions,such as vessel occlusion. Such treatment devices include devices forextracting vessel occluding material whether the material is connectedto the vessel or floating in the stream of fluid within the vessel.Needles, burrs, and blades, for example, are sometimes used in removingoccluding material from a lumen forming a vessel. Additionally,filtering devices are utilized to remove material that is entrainedwithin the flow of fluid in the vessel. These devices, either singly orin combination, operate to extract vessel occluding material.

Further, in some cases it is desirable to work at the center of theoccluded region because it can be less occluded and can also be easierto remove, since the material at the center of the occlusion is likelynewer material. Additionally, in some situations it is necessary to passa treatment device through an occluded region. For example, whenutilizing a filter, guidewire, or other device delivered from anupstream position, it is necessary to pass the device through theoccluded region so that the filter or other device can be deployeddownstream. In either of the above cases, the centering of the treatmentdevice can be difficult to achieve and therefore these procedures cantake a significant amount of time and require significantmaneuverability of the treatment device before the objectives of thetreatment are obtained.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an embodiment of the present invention in itsunexpanded state.

FIG. 1B illustrates the embodiment of FIG. 1A in its expanded state.

FIG. 1C illustrates an end view of the embodiment of FIG. 1B.

FIG. 2A illustrates an embodiment of the present invention beingpositioned in a vessel.

FIG. 2B illustrates the embodiment of FIG. 2A in a deployed state.

FIG. 3A illustrates another embodiment of the present invention in itsunexpanded state.

FIG. 3B illustrates the embodiment of FIG. 3A in its expanded state.

FIG. 4A illustrates an embodiment of the present invention beingpositioned in a vessel.

FIG. 4B illustrates the embodiment of FIG. 4A in a deployed state.

FIG. 5A illustrates an embodiment of the present invention beingpositioned in a vessel.

FIG. 5B illustrates the embodiment of FIG. 5A in a deployed state.

FIG. 5C illustrates another embodiment of the present invention in adeployed state.

FIG. 5D illustrates an end view of the embodiment of FIG. 5C.

FIG. 5E illustrates another embodiment of the present invention in adeployed state.

FIG. 6A illustrates an embodiment of the present invention beingpositioned in a vessel.

FIG. 6B illustrates the embodiment of FIG. 6A in a deployed state.

FIG. 7A illustrates an embodiment of the present invention beingpositioned in a vessel.

FIG. 7B illustrates the embodiment of FIG. 7A in a deployed state.

FIG. 8A illustrates another embodiment of the present invention.

FIG. 8B illustrates a cross-section of the embodiment of FIG. 8A takenalong line 8B-8B

FIG. 8C illustrates the embodiment of FIG. 8A in a deployed state.

FIG. 9A illustrates another embodiment of the present invention in itsexpanded state.

FIG. 9B illustrates area 9B of the embodiment of FIG. 9A in detail.

FIG. 9C illustrates an embodiment of a hinge such as that utilized inthe embodiment of FIG. 9B.

FIG. 10 illustrates a method embodiment of the present invention.

FIG. 11 illustrates another method embodiment of the present invention.

DETAILED DESCRIPTION

The present invention relates to methods, systems, and devices forextracting vessel occluding material, such as emboli and thrombi, from avessel. The following description is presented to enable one of ordinaryskill in the art to make and use the invention and is provided in thecontext of a patent application and its requirements. Variousmodifications to the embodiments shown will be readily apparent to thoseskilled in the art and are intended to be within the scope of thepresent invention. Thus, the present invention is not intended to belimited to the embodiments shown, but is to be accorded the widest scopeconsistent with the claims.

Those skilled in the art will appreciate from this disclosure thatvessel occluding material, such as thrombi and emboli, can include anymaterial that is to be removed or filtered, including, but not limitedto blood clots, and plaque, among others. Additionally, those skilled inthe art will appreciate that the term “occlusion” as used hereinincludes partial or complete blockage of a vessel by vessel occludingmaterial.

As described herein, the embodiments of the vessel occluding materialextractor can serve many different purposes. For example, variousembodiments of the device can be utilized as a filter or trap, to breakup or capture emboli flowing in the fluid stream within a vessel. Theembodiments shown in FIGS. 1A-1B are such embodiments and are discussedin detail below. Various embodiments of the device can be utilized invarious positioning embodiments such as shown in FIGS. 5A-5Eillustrates. Various embodiments of the device can also be utilized tohold the host device in place within the vessel to allow a treatmentdevice to be advanced along its length as the embodiment shown in FIGS.6A and 6B illustrate. Embodiments of the device can also be utilized toscore the surface of occluding material, blocking the fluid flow in avessel, as shown in FIGS. 7A and 7B. Additionally, in embodiments havinga catheter, the catheter can be used to, for example, to deliver drugsor treatment devices such as in the embodiment of FIGS. 8A-8C, can beutilized to remove the vessel occluding material, such as by a suctionapplied through the catheter, or for other suitable functions, theinvention is not so limited. Additionally, FIGS. 9A-9C illustrateanother embodiment of the invention having hinged expandable members.However, the invention is not so limited.

FIGS. 1A-1C illustrate a device embodiment of the present invention.FIG. 1A illustrates the embodiment in its unexpanded state, while FIG.1B illustrates the embodiment in its expanded state. FIG. 1C illustratesan end view of the embodiment shown in FIGS. 1A and 1B.

As shown in the embodiment of FIG. 1A, a vessel occluding materialextracting device 100 includes a host structure 102, having an elongateaxis, and an expandable portion 103. Those skilled in the art willappreciate that a host structure can be a catheter, a wire, or the like.The invention is not so limited. As shown in the embodiments of FIGS.1A-1C, the expandable portion 103 includes a plurality of expandablemembers 112, a first collar 110-1, a second collar 110-2, and acircumferential member 114.

In various embodiments, the expandable members 112 are connected to thehost structure and arrayed radially around the elongate axis in anaxially aligned manner. Those skilled in the art will appreciate thatthe expandable members can be constructed from any suitable materialknown in the art. Some suitable examples include metals, such as springsteel, super-elastic materials, such as Nitinol, polymers, or fabrics,among others.

Additionally, those skilled in the art will appreciate from reading thisdisclosure that the expandable members can be connected to the hoststructure in any manner that allows the extracting device to expand. Forexample, in the embodiment shown in FIGS. 1A-1C, the expandable members112 are connected to first collar 110-1 at one end and second collar110-2 at another end. The first and second collars 110-1 and 110-2 areconnected to the host device 102. In various embodiments, one or bothends of the expandable members 112 are moveable with respect to eachother.

In the embodiment shown in FIGS. 1A-1C, first collar 110-1 is slidablyconnected to the host structure 102 and can move from one position onthe host structure 102 to another. The second collar 110-2 is fixedlyattached to a distal end of the host device 102. In this embodiment, theslidable movement of the first collar 110-1 causes the expandablemembers 112 to bend when the ends of the expandable members 112 movetoward one another. The bending results in the expansion of the diameterof the expandable portion 103. This is illustrated in the difference indiameter of the expandable portion 103 in FIGS. 1A and 1B. One ofordinary skill in the art will recognize numerous manners in whichcollar 110-1 and/or collar 110-2 can be actuated.

The second collar 110-2, in this embodiment, is affixed inside the hoststructure 102 with one end of the expandable members 112 bent around theend of the host structure 102. However, the invention is not so limited.For example, in various embodiments where an extraction device isconnected to a host wire, both ends of the expandable members will beconnected, either fixedly or movably, to the exterior of the host wire.

In various embodiments, the expandable portion 103 includes acircumferential member 114. In various embodiments, as shown in FIGS.1A-1C, the circumferential member 114 can be utilized to maintain agenerally uniform lateral spacing between the expandable members 112. Invarious embodiments, the circumferential member 114 can be constructedto limit the expansion of the expandable members 112. In variousembodiments, the circumferential member 114 is non-elastic and connectedgenerally mid way between the ends of the expandable members. In theseembodiments, circumferential member 114 can retract to an unexpandedstate, shown in FIG. 1A, to reduce its diameter. In various embodiments,circumferential member 114 is elastic and expands when the expandableportion 103 is moved from the unexpanded state in FIG. 1A to theexpanded state in FIG. 1B.

Those skilled in the art will appreciate that the circumferential membercan be constructed from any suitable material known in the art and canbe either elastic or inelastic. Some suitable examples include metals,such as spring steel or Nitinol, polymers, or fabrics, among others.Those skilled in the art will also appreciate that the circumferentialmember 114 can be connected to the expandable members in any manner, forexample soldering, gluing, and tying, among others. The invention is notso limited.

In FIG. 1C, the device 100 is shown in an expanded state having twelve(12) expandable members 112, although the invention is not limited to 12expandable members. In the embodiment shown, the circumferential member114 can be connected to each expandable member 112 and when expanded, asshown, can operate to serve as a filter or vessel occluding materialtrap.

In various embodiments, the device can be utilized wherein substantialforce could be applied to the expandable members. In these embodiments,the device can be constructed from a material that can be deformed andsubstantially returned to its original shape. Examples of such materialsinclude plastics, polymers, stainless steel, and the like. However, theinvention is not so limited.

FIGS. 2A and 2B illustrates an embodiment of the present invention beingpositioned in a vessel. In these Figures, the device is utilizeddownstream from an occlusion. The device operates to filter and/or trapemboli, for example emboli broken loose from an occlusion by a treatmentdevice and entrained in the fluid flowing within a vessel.

In FIG. 2A, the device 200 is inserted into a vessel 220 from a locationupstream of an occluded region 230. Those skilled in the art willappreciate that in some situations, such as when vessel occludingmaterial completely occludes a vessel, such as with a total occlusion orchronic total occlusion (CTO), the device 200 can be inserted at a pointdownstream from the occlusion 230. In the embodiment shown in FIG. 2A,the device 200 is guided through the occluded region 230 along guidewire206 and is positioned downstream of the occlusion 230.

As shown in FIG. 2B, once the device 200 is positioned at a desiredlocation in the vessel 220, it can be expanded by expanding theexpandable portion 203. The expanded device 200 can operate as afilter/trap device by allowing fluid to flow between the expandablemembers 212, while restricting the space through which emboli can pass,thereby catching or filtering emboli with the expandable members 212.The device 200 can then be retracted and the emboli removed therewith.

In various embodiments, the device 200 can have an expanded diameterlarge enough to engage the walls of the vessel 220 such that the forcebetween the device and the wall of the vessel 202 holds the device 200in position. However, those skilled in the art will appreciate that thedevice 200 can also have an expanded diameter smaller than the diameterof the vessel 220 thereby allowing the device 200 to be movable withinthe vessel 220 while in its expanded state. This allows for adjustmentof the positioning of the device 200 and allows for the device 200 to beutilized in situations when the positioning of the occlusion 230 is suchthat engaging the walls of the vessel 220 is impractical.

FIGS. 3A and 3B illustrate another embodiment of a vessel occludingmaterial extractor that can be utilized as a filter and/or trap for thestraining and/or capturing of emboli therein. In this embodiment, thedevice 300 has a filtering material 316 connected thereon to aid infiltering and trapping emboli entrained in the fluid flowing through thevessel 320. In FIG. 3A, an embodiment of a device 300 is illustrated inits unexpanded state prior to reaching its destination within the vessel320, while in FIG. 3B, the device 300 is illustrated in its expandedstate.

In the embodiment shown in FIGS. 3A and 3B, the device 300 has a hoststructure 302, and an expandable portion 303 having two collars 310-1and 310-2, a plurality of expandable members 312, a circumferentialmember 314, filtering material 316, and a recessed section 318. Thedevice 300 has a filtering material 316 connected to the distal end ofthe expandable members 312.

In various embodiments, the filtering material 316 has a plurality ofpores formed therein. As one of ordinary skill in the art willappreciate, the plurality of pores on the filtering material 316 allowfor the passing of fluid there-through and provide for the filtering ofemboli. The pores in the filtering material 316 can be of any sizesuitable to implement the various aspects of the present invention. Theinvention is not so limited.

Those skilled in the art will also appreciate from reading thisdisclosure that the filtering material 316 can be constructed of anysuitable material. The invention is not so limited. For example, thematerial can be a plurality of wires, such as stainless steel orNitinol, can be a fabric, or can be a sheet of material, among others.Additionally, those skilled in the art will appreciate from reading thisdisclosure that the circumferential member 314 and the filter material316 can be connected, and/or can be formed as a single unit.

In the embodiment shown in FIGS. 3A and 3B, the device 300 also has astop mechanism therein that can restrict the expansion and/or theretraction of the device 300. For example, in the embodiment shown, thedevice 300 has a recessed section 318 formed in the exterior surface ofthe host structure 302. A collar 310-1 is slidably connected to the hoststructure 302 within the recessed section 318. In the embodiment shown,the collar 310-1 and recessed section 318 are constructed and arrangedsuch that the ends of the recessed section 318 form stops that impedethe movement of the collar 310-1 in both the distal and proximaldirections, the invention, however, is not so limited. In variousembodiments, the collar 310-1 can be designed such that its exteriordiameter, including the expandable members 312 connected thereto, is thesame or smaller than the larger exterior diameter of the host device302. The invention, however, is not so limited.

Those skilled in the art will appreciate that one or more stopmechanisms other than that shown in FIGS. 3A and 3B can be provided toarrest directional movement of a collar, e.g. 310-1, or the expandableportion 303. The invention is not so limited. For example, a stopmechanism can be one or more areas on the host device having a larger orsmaller diameter than the general diameter of the host device. Thoseareas can extend around the entire circumference of the host device oraround a portion of the circumference, the invention is not so limited.

Those skilled in the art will also appreciate from reading thisdisclosure that one or more of the expandable members 312 can have ahollow interior, e.g. 313, formed therein for the communication of drugsor medication to a treatment site, such as occluded region 330.Additionally, the hollow interior 313 within the one or more expandablemembers 312 can connect with a reservoir located on the device 300 toretain drugs or medication therein. Those skilled in the art willunderstand that the delivery of the drug to the hollow interior 313 canbe by any manner and that a reservoir can be formed in any manner, suchas a reservoir demonstrated in FIGS. 8A-8C, among others. The inventionis not so limited.

FIGS. 4A and 4B illustrate a procedure in which an extraction device,such as that shown in FIGS. 3A and 3B could be utilized. In theseFigures, the device is utilized downstream from an occlusion andoperates to filter and/or trap emboli, for example emboli broken loosefrom an occlusion by a treatment device and entrained in the fluidflowing within the vessel. In FIG. 4A, an embodiment of a device 400 isillustrated in its unexpanded state prior to reaching its destinationwithin the vessel 420. In FIG. 4B, the device 400 is illustrated in itsexpanded state.

In FIG. 4A, the device 400 is inserted into the vessel 420 from alocation upstream of the occluded region 430. In various embodiments,such as when vessel occluding material completely occludes a vessel,e.g. CTO, the device 402 can be inserted at a point downstream from theocclusion 430. In the embodiment shown in FIG. 4A, the device 400 isguided through the occluded region 430 and is positioned downstream ofthe occlusion 430.

In this embodiment, the pore size of the filter material 416 is smallerthan the space between the expandable members 412. Accordingly, thisembodiment allows for the filtration and/or capture of smaller embolithan the device 300 of FIGS. 3A and 3B. Those skilled in the art willappreciate that one or more filters having varying pore sizes, such asthose shown in FIGS. 1A-4B, can be utilized in combination to break uplarge emboli with a filter having large pores before they reach thepores of a filter having smaller pores.

FIGS. 5A-5E illustrate several embodiments of the present inventionbeing positioned in a vessel. In FIGS. 5A and 5B, illustrate anotherembodiment of the present invention being positioned in a vessel. FIGS.5A and 5B illustrate the device 500 being positioned and deployed in avessel 520 for centering and/or stabilization of a host structure 502.The centering and/or stabilization of a host structure can allow forbetter navigation and stability for passing a treatment device into anopening in an occlusion as well as for breaking through a fullocclusion, such as a CTO.

In FIG. 5A, an embodiment of a device 500 is illustrated in itsunexpanded state prior to reaching its destination within a vessel 520.In FIG. 5B, the device 500 has reached its destination and has beendeployed into its expanded state.

As shown in FIG. 5A, the device 500 includes a host structure 502 havingan expandable portion 503 connected thereto. In the embodiments of FIGS.5A and 5B, the expandable portion 503 includes collars 510-1 and 510-2,expandable members 512, and circumferential member 514. In variousembodiments, the device 500 travels through vessel 520 along a guidecatheter or guidewire 506. In the embodiment shown in FIG. 5A, theextracting or centering device 500 is positioned proximal to an occludedregion 530 in need of treatment. In this embodiment, a guidewire 506 isutilized to penetrate and cross the occluded region 530. In variousembodiments, other treatment devices can be utilized.

As shown in FIG. 5B, the device 500 can be expanded to providecentralized positioning and/or stability to the delivery of a treatmentdevice, e.g. guidewire 506. For example, in the embodiment shown in FIG.5B, the device 500 is also expanded to engage the walls of the vessel520 to hold it in place. In this way, the device 500 can provide astable platform proximate to the treatment area 530 from which to launcha treatment device, e.g. guidewire 506. This can be accomplished byexpanding the expandable portion 503 to restrict the amount of space inwhich the device 500 can move and, thereby, restrict the movement of thehost structure 502. In this way, the device 500 can allow for atreatment device, such as a guidewire 506, to be generally centered inthe vessel 520 at a position that is proximal to a region 530 needingtreatment.

By having a stable structure proximate to the treatment site, there canbe less risk of buckling the treatment device when it is in contact withthe occluded region and can allow for more push force to be applied tothe treatment device. This increased push-ability can allow for smallerdiameter and more flexible guidewires and host wires to be utilized.Additionally, when an embodiment of the present invention is utilizedsuch that it is held in place within a vessel, the device allows for aguidewire to be withdrawn without losing the advanced position.

FIGS. 5C and 5D, illustrate another embodiment of the present inventionbeing positioned in a vessel. As shown in FIG. 5C, the device 500includes a host structure 502 having an expandable portion 503 connectedthereto. In the embodiment of FIG. 5C, the expandable portion 503includes collars 510-1 and 510-2, expandable members 512, andcircumferential member 514. In this embodiment, a guidewire 506 can beutilized to penetrate and cross the occluded region 530. However, othertreatment devices can be utilized. The invention is not so limited.

As shown in FIG. 5C, the device 500 can be expanded to providedecentralized positioning and/or stability to the delivery of atreatment device, in this case guidewire 506 as has been describedpreviously herein. Those skilled in the art will appreciate from readingthis disclosure that a decentralized position can be accomplished in anymanner.

For example, FIG. 5D, illustrates an end view of the embodiment shown inFIG. 5C. As shown in FIG. 5D, in this embodiment, one or more of theexpandable members have different spring strengths such that someexpandable members bend more readily than others. In the embodimentshown, in FIGS. 5C and 5D, the expandable members 512-1 have a firstspring strength and the expandable members 512-2 have a second springstrength that is less than the first spring strength of members 512-1.

A decentralized position can be accomplished by utilizing irregularspacing between the expandable members 512. For example, as shown inFIG. 5D, since the expandable members 512-2 have a greater springstrength, they expand the circumferential member 514 out more. Thischanges the centering of the host structure 502, thereby, moving thehost structure 502 to a decentralized position. Examples, of othermanners in which decentralizing can be accomplished include, shorteningsome of the expandable members 512 and arraying the expandable members512 in a non-uniform manner about the host structure 502, among others.The invention is not so limited.

In FIG. 5E, illustrate another embodiment of the present invention beingpositioned in a vessel. In FIG. 5E, the device 500 includes a hoststructure 502 having two or more expandable portions 503 connectedthereto. In the embodiment of FIG. 5E, the expandable portions 503include collars 510-1 and 510-2, expandable members 512, andcircumferential member 514. In the embodiment shown in FIG. 5A, theextracting device 500 is positioned proximal to an occluded region 530in need of treatment. In this embodiment, a guidewire 506 is utilized topenetrate and cross the occluded region 530. In various embodiments,other treatment devices can be utilized.

As shown in FIG. 5E, the device 500 can be expanded to providecentralized positioning and additional stability to the delivery of atreatment device, e.g. guidewire 506. For example, in the embodimentshown in FIG. 5E, the expandable portions 503 of the device 500 expandedto engage the walls of the vessel 520 to hold the device 500 in place.In this way, the device 500 can provide a stable platform proximate tothe treatment area 530 from which to launch a treatment device, e.g.guidewire 506 as has been described previously herein.

In various embodiments, the expandable portions 503 can be covered in anon-porous material and, thereby, once the portions 503 are expanded,the portions 503 can act to isolate a section of vessel 520 that islocated between the portions 503 from the flow of fluid through thevessel 520. In such embodiments, a number of fluid lumens, such as areshown in the embodiment of FIGS. 8A-8C at 824 can be formed in the hoststructure 502 of the embodiment shown in FIG. 5E. In this way, fluidflowing in the vessel 520 can continue to flow while the device 500 isisolating a section for treatment between portions 503. Additionally, insuch an embodiment, the drug delivery can be provided through aperturesformed in the host structure 502 between the two expandable portions503.

FIGS. 6A and 6B illustrate an embodiment of the present invention beingpositioned in a vessel. The figures illustrate a vessel occludingmaterial extractor being inserted and deployed in a vessel to aid in thedelivery of a treatment device. In FIG. 6A, an embodiment of a device600 is illustrated in its unexpanded state, while in FIG. 6B, the device600 is illustrated, in its expanded state, deployed within a vessel 620.

As with FIGS. 5A and 5B, the embodiment illustrated in FIGS. 6A and 6Bis shown being utilized as a centering device to center a host structure602, in this case a catheter, within the vessel 620. This function canallow for a treatment device 608. In the embodiment shown in FIG. 6B,the treatment device is a needle. However, the invention is not solimited. Those skilled in the art will appreciate that a host structurecan be a catheter or wire, among others. The invention is not solimited.

In the embodiments of FIGS. 6A and 6B, a device 600 has a host structure602 and an expandable portion 603. The expandable portion 603 includescollars 610-1 and 610-2, expandable members 612, and circumferentialmember 614. In various embodiments, the device 600 travels throughvessel 620 along a guide catheter or guidewire 606. In the embodimentshown in FIG. 6A, the extracting device 600 is positioned proximal to anoccluded region 630 in need of treatment. In this embodiment, a needle608 is utilized to penetrate and cross the occluded region 630.

A treatment device such as needle 608 can be operable to provide severalfunctions. The invention is not so limited. For example, needle 608 canbe utilized to take a sample of the occluding material from the occludedregion 630. In this way, for example, the type of material, itsfibrosity, and general internal makeup can be determined.

The needle 608 can also aid in treating an occlusion by loosening orextracting some of the occluded material at the region 630. For example,the needle 608 can be utilized to push through the occluded region 630,in cases of total occlusion or chronic total occlusion (CTO).

In various embodiments, the needle 608 can be utilized to measure thelength of the occluded region 630, through use of a radiopaque needletip or by examination of the length of a core sample taken from theoccluded region. The measurement can, for example, be used to helpdetermine the types of treatment options that are available. By way ofexample and not by way of limitation, information on the length of theocclusion can be used to determine the size and the length of stent tobe utilized to recanalize the vessel.

Additionally, the needle 608 can also be utilized to administeranti-thrombogenic or anti-embolic drugs to an area in need of treatmentsuch as for example, region 630. Those skilled in the art willappreciate from this disclosure that any treatment device can beutilized with various embodiments of the invention and that theinvention can be utilized for any suitable treatment application in anyarea of the body, including but not limited to vascular, renal,esophageal, and stomach, among others. Some examples of treatmentdevices include, but are not limited to radiation sources, burrs,blades, filters, drug delivery devices, needles, optical fibers,guidewires, and catheters, among others.

In the embodiments of FIGS. 7A and 7B, a device 700 has a host structure702 and an expandable portion 703. In various embodiments, theexpandable portion 703 includes a plurality of expandable members 712, afirst collar 710-1, a second collar 710-2, and a circumferential member714. In various embodiments, the device 700 travels through vessel 720along a guide catheter or guidewire 706.

In the embodiment shown in FIG. 7A, the device 700 is positionedproximal to an occluded region 730 in need of treatment. In thistechnique, the device 700 is placed proximal to the surface of theoccluded region 730, and the end surface of the device 700 is utilizedto score, loosen, and/or remove vessel occluding material. In varioustechniques, the extended ends of the expandable members 712 are movableas has been described in detail herein.

In this embodiment, shown in FIG. 7B for example, expandable members 712can be operable to score and/or loosen occluded material from theoccluded region 730. Those skilled in the art will appreciate that theexpandable members 712 can be sharpened to provide better scoring of theoccluding material, whether distal to the device 700 or between thedevice and the walls of the vessel 720.

In various techniques for example, first collar 710-1 can be moved awayfrom the expandable portion 703 to bend the expandable members outward,near second collar 710-2 and can be accomplished either before or aftercontact with the occluding material. In various embodiments, the firstcollar 710-1 can be moved away and toward the expandable portion 703repeatedly, thereby moving the expandable members 712. Additionally,once the device 700 is positioned, it can be expanded, as the same hasbeen described herein. These movements can aid in loosening and scoringthe occluded material of the occluded region 730.

FIGS. 8A-8C, illustrate another embodiment of the present inventionbeing positioned in a vessel. In the embodiment of FIGS. 8A, 8B, and 8C,a device 800 has a host structure 802 and an expandable portion 803. Invarious embodiments, the expandable portion 803 includes a collar 810,expandable members 812, and reservoir material 814. In variousembodiments the host structure includes a delivery lumen 822 terminatingin an aperture at 826. This lumen 822 can be utilized for the deliveryof materials, such as drugs or medications, among others. Additionally,in various embodiments, the host structure 802 can include a fluid flowlumen 824. The blood flow lumen has one or more access ports 828 thatallow fluid flowing through the vessel to be diverted into the lumen 824and then out the distal end of the device 800.

FIG. 8B illustrates a cross-section of the host structure 802. ThisFigure illustrates the two lumens 822 and 824 formed therein. Althoughshown in a side-by-side relation, those skilled in the art willappreciate that the two lumens can be substantially co-axial and thatthe sizes of the respective lumens 822 and 824 can be any suitablesizes. The invention is not so limited.

In various embodiments, as shown in FIG. 8C, the device 800 is deployedwithin a vessel 820. In the embodiment shown in FIG. 8C, the device 800is positioned over an occluded region 830 in need of treatment. Invarious embodiments, when the device 500 is expanded, the expandablemembers 812 bend outward and expand reservoir material 814 to create areservoir therein. The reservoir is connected through aperture 826 tolumen 822, thereby allowing the reservoir to house material providedthrough the lumen 822. In various embodiments, the reservoir material814 has one or more holes 816 therein. The holes 816 allow one or morefluids, such as liquids, housed within the reservoir to be dispensedinto the vessel 820. As shown in FIG. 8C, the device 800 can be sizedsuch that when expanded, a part of the expandable portion 803 isolates asection of the vessel 820. In the case shown in FIG. 8C, the isolatedsection of the vessel 820 contains occluding material 830 thereon. Byisolating this section of the vessel 820, the device 800 can be utilizedto provide drugs or medications, among others, to the occluding material830 through use of lumen 822 in communication with the reservoir and theholes 816 formed in the reservoir material 816. In the embodiment shownin FIG. 8C, the device 800 also includes a fluid lumen 824 to allow thefluid flowing through the vessel 820 to continue to pass through thevessel 820 while the device 800 is deployed.

In the embodiments of FIGS. 9A-9C, a device 900 has a host structure 902and an expandable portion 903. In various embodiments, the expandableportion 903 includes a plurality of expandable members 912, a firstcollar 910-1, a second collar 910-2, and a circumferential member 914.In various embodiments, the expandable members 912 are formed from anumber of sections. In various embodiments, the number of sections of anexpandable member 912 are hinged together to allow the expandable memberto expand.

For example, in the embodiment of FIG. 9A a hinge structure as shown indetail in FIGS. 9B and 9C includes a first section 920 and a secondsection 922 movably engaged by a pin 924. The engagement allows one orboth sections 920 and 922 to move with respect to each other. In variousembodiments, as shown in FIG. 9B, the hinging mechanism includes one ormore arresting structures 926. In the embodiment shown in FIG. 9B, thearresting structure 926 contacts the surface 928 of section 922 toarrest the counterclockwise movement of the section 922. However, theinvention is not so limited.

FIGS. 10 and 11 are block diagrams illustrating method embodiments ofthe invention. As those skilled in the art will appreciate from readingthis disclosure, unless explicitly stated, the methods described hereinare not constrained to a particular order or sequence. Additionally,some of the so described methods or parts of a single method can occuror be performed at the same point in time.

FIG. 10 illustrates a method of extracting vessel occluding material. Inthe embodiment of FIG. 10, the method includes advancing vesseloccluding material extractor, having longitudinally aligned expandablemembers at block 1010. In various embodiments, advancing a vesseloccluding material extractor, includes advancing a vessel occludingmaterial extractor having material spanning between a distal half of theplurality of expandable members to form a filter. In variousembodiments, advancing a vessel occluding material extractor, includesadvancing a vessel occluding material extractor having a circumferentialmember connected to the expandable members.

The method of FIG. 10 also includes actuating the members to an expandedstate to serve as a clot filter at block 1020. In various embodiments,actuating the members includes bending the expandable members to expandthe extractor to an expanded state to form a filtering device.

FIG. 11 illustrates a method embodiment for extracting vessel occludingmaterial. In the embodiment of FIG. 11, the method includes advancing acentering device, having a plurality of expandable members and anelongate central axis, to a predetermined position within a lumen, thecentering device having a first diameter at block 1110. In variousembodiments, the centering device includes a catheter centered along thecentral axis.

The method of the embodiment of FIG. 11 also includes expanding theexpandable members to expand the centering device to have a seconddiameter larger than the first diameter at block 1 120. In variousembodiments, expanding the expandable members includes manuallyexpanding the expandable members. However, the invention is not solimited.

The method of FIG. 11 further includes advancing a treatment devicegenerally parallel to the elongate central axis of the centering deviceat block 1130. In various embodiments, advancing a centering deviceincludes advancing the centering device along a guidewire. In variousembodiments, advancing a treatment device includes advancing a treatmentdevice through the catheter of the centering device. In variousembodiments, advancing a treatment device includes advancing a treatmentdevice along the central axis of the centering device.

The method of the embodiment illustrated in FIG. 11 includes positioningthe treatment device proximate the centering device at block 1140. Invarious embodiments, positioning the treatment device proximate thecentering device includes positioning the treatment device on theproximal side of the centering device with respect to the direction thetreatment device is advanced. And, in various embodiments, positioningthe treatment device proximate the centering device includes positioningthe treatment device on the distal side of the centering device withrespect to the direction the treatment device is advanced.

Although specific embodiments have been illustrated and describedherein, those of ordinary skill in the art will appreciate that anyarrangement calculated to achieve the same techniques can be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments of theinvention. It is to be understood that the above description has beenmade in an illustrative fashion, and not a restrictive one. Combinationof the above embodiments, and other embodiments not specificallydescribed herein will be apparent to those of skill in the art uponreviewing the above description. The scope of the various embodiments ofthe invention includes any other applications in which the abovestructures and methods are used. Therefore, the scope of variousembodiments of the invention should be determined with reference to theappended claims, along with the full range of equivalents to which suchclaims are entitled.

It is emphasized that the Abstract is provided to comply with 37 C.F.R..sctn. 1.72(b) requiring an Abstract that will allow the reader toquickly ascertain the nature of the technical disclosure. It issubmitted with the understanding that it will not be used to limit thescope of the aims.

In the foregoing Detailed Description, various features are groupedtogether in a single embodiment for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

What is claimed:
 1. A method of extracting vessel occluding material, comprising; advancing a vessel occluding material extractor, having a plurality of expandable members connected to a host structure having an elongate axis, and longitudinally aligned and arrayed radially around the elongate axis, to a predetermined position within a lumen, wherein the expandable members have an unexpanded state having a first diameter for advancing the extractor bending the expandable members to expand the extractor to an expanded state, having a second diameter larger than the first diameter; and advancing a treatment device including a radiopaque tip through and beyond the vessel occluding material extractor, wherein the length of an occluded region distal of the predetermined position within the lumen is determined by advancing the treatment device through and beyond the vessel occluding material extractor.
 2. The method of claim 1, wherein advancing a vessel occluding material extractor, includes advancing a vessel occluding material extractor having material spanning between a distal half of the plurality of expandable members to form a filter.
 3. The method of claim 1, wherein advancing a vessel occluding material extractor, includes advancing a vessel occluding material extractor having a circumferential member connected to the expandable members.
 4. The method of claim 1, wherein bending the expandable members to expand the extractor to an expanded state includes bending the expandable members to form a filtering device.
 5. The method of claim 1, further including the step of using the determined length of the occlusion to determine the size and length of stent to be utilized to recanalize the vessel.
 6. A method of extracting vessel occluding material, comprising; advancing a positioning device, having a plurality of expandable members and an elongate central axis, to a predetermined position within a lumen, the positioning device having a first diameter; expanding the expandable members to expand the positioning device to have a second diameter larger than the first diameter; advancing a treatment device including a radiopaque tip within and generally parallel to the elongate central axis of the positioning device; and positioning the treatment device proximate the positioning device, wherein the length of an occluded region distal of the predetermined position within the lumen is determined by advancing the treatment device through and beyond the vessel occluding material extractor.
 7. The method of claim 6, wherein the positioning device includes a catheter centered along the central axis.
 8. The method of claim 7, wherein advancing a positioning device includes advancing the positioning device along a guidewire.
 9. The method of claim 7, wherein advancing a treatment device includes advancing a treatment device through the catheter of the positioning device.
 10. The method of claim 6, wherein advancing a treatment device includes advancing a treatment device along the central axis of the positioning device.
 11. The method of claim 6, wherein expanding the expandable members includes manually expanding the expandable members.
 12. The method of claim 6, wherein positioning the treatment device proximate the positioning device includes positioning the treatment device on the proximal side of the positioning device with respect to the direction the treatment device is advanced.
 13. The method of claim 6, wherein positioning the treatment device proximate the positioning device includes positioning the treatment device on the distal side of the positioning device with respect to the direction the treatment device is advanced.
 14. The method of claim 6, further including the step of using the determined length of the occllusion to determine the size and length of stent to be utilized to recanalize the vessel. 